COVID-19, SARS-CoV-2Phase 1NCT05932641
Study of AZD3152 Intramuscular Injection or Intravenous Infusion in Healthy Japanese Adult Participants
A Phase 1 study testing AZD3152 (Cohort 1), AZD3152 (Cohort 2) and AZD3152 (Cohort 3) in people with COVID-19, SARS-CoV-2, run by AstraZeneca at 1 site in Japan.
Trial summary
AZD3152 is being evaluated for administration to prevent COVID-19. This Phase I study will gather important information on the safety and tolerability of AZD3152 as well as relevant data on the PK, PD (as the neutralising responses against SARS-CoV-2) profile and the generation of ADA to AZD3152. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV-2
- What is being tested?
- AZD3152 (Cohort 1), AZD3152 (Cohort 2) and AZD3152 (Cohort 3)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- 31 Jul 2023to 5 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese men and women and 18 to 55 years of age inclusive, at the time of signing the informed consent.
- No positive results of SARS-CoV-2 NAT and/or rapid antigen tests.
- Healthy participants by medical history, physical examination, baseline safety laboratory studies, and screening parameters, according to the judgement of the investigators, with no concomitant disease or concomitant medication.
- ECG without clinically significant abnormalities.
- Able to complete the Follow-up Period through Day 361 as required by the protocol.
- Body weight ≥ 45 kg and ≤ 110 kg and BMI ≥ 18.0 to ≤ 30.0 kg/m2.
Who cannot join
- Known hypersensitivity to any component of the IMP.
- History of allergic disease or reactions likely to be exacerbated by any component of the IMP.
- Previous hypersensitivity, infusion related reaction or severe adverse reaction following administration of mAbs.
- Fever above 38.0°C on day prior to or on day of randomisation/dosing.
- AST, ALT or serum creatinine above ULN; bilirubin and ALP >1.5 × ULN.
- Any vaccination except for COVID-19 vaccine (e.g., inactivated influenzae vaccine) planned.
- SARS CoV-2 or COVID-19:
- Receipt of a COVID-19 vaccine within 3 months. COVID-19 infection within 3 months prior.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3152 in Healthy Japanese Adults
AZD3152 is being evaluated for administration to prevent COVID-19. This Phase I study will gather important information on the safety and tolerability of AZD3152 as well as relevant data on the PK, PD (as the neutralising responses against SARS-CoV-2) profile and the generation of ADA to AZD3152.
Read the detailed description
This is a Phase I, randomised, double-blind, placebo controlled study evaluating the safety, tolerability, PK and PD of AZD3152 in healthy Japanese adult participants, 18 to 55 years of age. Approximately 24 healthy participants will be randomised at up to 2 study sites.
- Conditions
- COVID-19, SARS-CoV-2
- Being tested
- AZD3152 (Cohort 1), Placebo (Cohort 1), AZD3152 (Cohort 2), Placebo (Cohort 2), AZD3152 (Cohort 3)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3152 (Cohort 1)Biological
Single dose of AZD3152 300 mg IM on Visit 2 Day 1
Placebo (Cohort 1)Biological
Single dose of Placebo IM on Visit 2 Day 1
AZD3152 (Cohort 2)Biological
Single dose of AZD3152 600 mg IM on Visit 2 Day 1
Placebo (Cohort 2)Biological
Single dose of Placebo IM on Visit 2 Day 1
AZD3152 (Cohort 3)Biological
Single dose of AZD3152 1200 mg IV on Visit 2 Day 1
Placebo (Cohort 3)Biological
Single dose of Placebo IM on Visit 2 Day 1
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - AZD3152 300 mg IM direct anterolateral thigh injection | Experimental | Not described Receives: Biological: AZD3152 (Cohort 1) |
| Cohort 1 - Placebo IM direct anterolateral thigh injection | Placebo comparator | Not described Receives: Biological: Placebo (Cohort 1) |
| Cohort 2 - AZD3152 600 mg IM direct anterolateral thigh injection | Experimental | Not described Receives: Biological: AZD3152 (Cohort 2) |
| Cohort 2 - Placebo direct anterolateral thigh injection | Placebo comparator | Not described Receives: Biological: Placebo (Cohort 2) |
| Cohort 3 - AZD3152 1200 mg IV administration | Experimental | Not described Receives: Biological: AZD3152 (Cohort 3) |
| Cohort 3 - Placebo IV administration | Placebo comparator | Not described Receives: Biological: Placebo (Cohort 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of AZD3152 - AEs
Occurrence of AEs collected up to Visit 9 (Day 91)
Measured: Up to Visit 9 (Day 91)
To evaluate the safety and tolerability of AZD3152 - SAEs, MAAEs, and AESIs
Occurrence of SAEs, MAAEs, and AESIs collected up to Visit 12 (Day 361)
Measured: Up to Visit 12 (Day 361)
To evaluate the safety and tolerability of AZD3152 - Blood pressure
The following variables will be collected:
- Systolic Blood pressure
- Diastolic Blood pressure
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Pulse rate
Pulse rate will be collected
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Axillary temperature
Axillary temperature will be collected
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Respiratory rate
Respiratory rate will be collected
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval will be recorded
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Heart rate
Heart rate will be recorded
Measured: Up to Visit 7 (Day 29)
To characterise the Serum Pharmacokinetics of AZD3152 - Concentration at the end of infusion (Ceoi) (after intravenous only)
AZD3152 concentration over time and Pharmacokinetics parameters
Measured: Up to Visit 12 (Day 361)
To characterise the Serum Pharmacokinetics of AZD3152 - Maximum concentration (Cmax)
AZD3152 concentration over time and Pharmacokinetics parameters
Measured: Up to Visit 12 (Day 361)
To characterise the Serum Pharmacokinetics of AZD3152 - Time to maximum concentration (tmax)
AZD3152 concentration over time and Pharmacokinetics parameters
Measured: Up to Visit 12 (Day 361)
To characterise the Serum Pharmacokinetics of AZD3152 - Terminal half-life (t½)
AZD3152 concentration over time and Pharmacokinetics parameters
Measured: Up to Visit 12 (Day 361)
To characterise the Serum Pharmacokinetics of AZD3152 - Area under the concentration-time curve at the last measured time point (AUClast)
AZD3152 concentration over time and Pharmacokinetics parameters
Measured: Up to Visit 12 (Day 361)
To characterise the Serum Pharmacokinetics of AZD3152 - Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
AZD3152 concentration over time and Pharmacokinetics parameters
Measured: Up to Visit 12 (Day 361)
To evaluate the safety and tolerability of AZD3152 - Haematology - White blood cell count
The following will be collected:
- White blood cell count
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Red blood cell count
The following will be collected:
- Red blood cell count
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Haemoglobin
The following will be collected:
- Haemoglobin
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Haematocrit
The following will be collected:
- Haematocrit
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Mean corpuscular volume
The following will be collected:
- Mean corpuscular volume
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Mean corpuscular haemoglobin
The following will be collected:
- Mean corpuscular haemoglobin
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Mean corpuscular haemoglobin concentration
The following will be collected:
- Mean corpuscular haemoglobin concentration
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Neutrophils absolute count
The following will be collected:
- Neutrophils absolute count
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Lymphocytes absolute count
The following will be collected:
- Lymphocytes absolute count
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Monocytes absolute count
The following will be collected:
- Monocytes absolute count
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Eosinophils absolute count
The following will be collected:
- Eosinophils absolute count
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Basophils absolute count
The following will be collected:
- Basophils absolute count
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Platelets
The following will be collected:
- Platelets
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Haematology - Reticulocytes absolute count
The following will be collected:
- Reticulocytes absolute count
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Sodium
The following will be collected:
- Sodium
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Potassium
The following will be collected:
- Potassium
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Blood urea nitrogen
The following will be collected:
- Blood urea nitrogen
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Creatinine and estimated glomerular filtration rate
The following will be collected:
- Creatinine and estimated glomerular filtration rate
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Albumin
The following will be collected:
- Albumin
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Calcium
The following will be collected:
- Calcium
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Phosphate
The following will be collected:
- Phosphate
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Glucose
The following will be collected:
- Glucose
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - C reactive protein
The following will be collected:
- C reactive protein
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Alkaline phosphatase
The following will be collected:
- Alkaline phosphatase
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Alanine aminotransferase
The following will be collected:
- Alanine aminotransferase
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Aspartate aminotransferase
The following will be collected:
- Aspartate aminotransferase
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Gamma glutamyl transpeptidase
The following will be collected:
- Gamma glutamyl transpeptidase
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Total bilirubin
The following will be collected:
- Total bilirubin
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Unconjugated bilirubin
The following will be collected:
- Unconjugated bilirubin
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Conjugated bilirubin
The following will be collected:
- Conjugated bilirubin
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Creatine kinase
The following will be collected:
- Creatine kinase
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Troponin T and I
The following will be collected:
- Troponin T and I
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Urinalysis - Glucose
The following will be collected:
- Glucose
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Urinalysis - Blood
The following will be collected:
- Blood
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Urinalysis - Microscopy
The following will be collected:
- Microscopy
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Urinalysis - Protein
The following will be collected:
- Protein
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Coagulation - International normalised ratio
The following will be collected:
- International normalised ratio
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Coagulation - Activated partial thrombin time
The following will be collected:
- Activated partial thrombin time
Measured: Up to Visit 7 (Day 29)
To evaluate the safety and tolerability of AZD3152 - Coagulation - Prothrombin time
The following will be collected:
- Prothrombin time
Measured: Up to Visit 7 (Day 29)
Secondary outcomes (2)
To evaluate the Anti-Drug Antibody responses to AZD3152 in serum
Incidence of Anti-Drug Antibody to AZD3152 in serum
Measured: Up to Visit 12 (Day 361)
The serum neutralising responses against SARS-CoV-2 using geometric mean titer (GMT) and geometric mean fold rise (GMFR) from baseline
Blood samples as neutralising responses against SARS-CoV-2 in serum will be collected
Measured: Up to Visit 12 (Day 361)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start31 Jul 2023
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19, SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Phase I, randomised, double-blind, placebo controlled study evaluating the safety, tolerability, PK and PD of AZD3152 in healthy Japanese adult participants, 18 to 55 years of age. Approximately 24 healthy participants will be randomised at up to 2 study sites in a ratio of 6:2 in each cohort to either AZD3152 or placebo administered IM or IV, across 3 fixed-dose cohorts. To participants who will receive the IMP via IM injection (Cohorts 1 and 2), the IMP will be given as a direct anterolateral thigh IM administration of AZD3152 or placebo. To participants who will receive the IMP via IV infusion (Cohort 3), the IMP will be administered as an IV infusion containing AZD3152 or placebo. The randomisation of Cohort 2 and 3 should be performed sequentially.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932641
- Sponsor's protocol ID
- D7000C00007
- Status last verified
- Dec 2024
- First submitted
- 15 May 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3152 in Healthy Japanese Adults
- ClinicalTrials.gov ID
- NCT05932641
- Acronym / sponsor ID
- D7000C00007
- Conditions
- COVID-19, SARS-CoV-2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AZD3152 is being evaluated for administration to prevent COVID-19. This Phase I study will gather important information on the safety and tolerability of AZD3152 as well as relevant data on the PK, PD (as the neutralising responses against SARS-CoV-2) profile and the generation of ADA to AZD3152.
Detailed description
This is a Phase I, randomised, double-blind, placebo controlled study evaluating the safety, tolerability, PK and PD of AZD3152 in healthy Japanese adult participants, 18 to 55 years of age. Approximately 24 healthy participants will be randomised at up to 2 study sites.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- This is a Phase I, randomised, double-blind, placebo controlled study evaluating the safety, tolerability, PK and PD of AZD3152 in healthy Japanese adult participants, 18 to 55 years of age. Approximately 24 healthy participants will be randomised at up to 2 study sites in a ratio of 6:2 in each cohort to either AZD3152 or placebo administered IM or IV, across 3 fixed-dose cohorts. To participants who will receive the IMP via IM injection (Cohorts 1 and 2), the IMP will be given as a direct anterolateral thigh IM administration of AZD3152 or placebo. To participants who will receive the IMP via IV infusion (Cohort 3), the IMP will be administered as an IV infusion containing AZD3152 or placebo. The randomisation of Cohort 2 and 3 should be performed sequentially.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - AZD3152 300 mg IM direct anterolateral thigh injection | Experimental | Biological: AZD3152 (Cohort 1) |
| Cohort 1 - Placebo IM direct anterolateral thigh injection | Placebo comparator | Biological: Placebo (Cohort 1) |
| Cohort 2 - AZD3152 600 mg IM direct anterolateral thigh injection | Experimental | Biological: AZD3152 (Cohort 2) |
| Cohort 2 - Placebo direct anterolateral thigh injection | Placebo comparator | Biological: Placebo (Cohort 2) |
| Cohort 3 - AZD3152 1200 mg IV administration | Experimental | Biological: AZD3152 (Cohort 3) |
| Cohort 3 - Placebo IV administration | Placebo comparator | Biological: Placebo (Cohort 3) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Japanese men and women and 18 to 55 years of age inclusive, at the time of signing the informed consent.
- No positive results of SARS-CoV-2 NAT and/or rapid antigen tests.
- Healthy participants by medical history, physical examination, baseline safety laboratory studies, and screening parameters, according to the judgement of the investigators, with no concomitant disease or concomitant medication.
- ECG without clinically significant abnormalities.
- Able to complete the Follow-up Period through Day 361 as required by the protocol.
Key exclusion criteria (8 listed)
- Known hypersensitivity to any component of the IMP.
- History of allergic disease or reactions likely to be exacerbated by any component of the IMP.
- Previous hypersensitivity, infusion related reaction or severe adverse reaction following administration of mAbs.
- Fever above 38.0°C on day prior to or on day of randomisation/dosing.
- AST, ALT or serum creatinine above ULN; bilirubin and ALP >1.5 × ULN.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD3152 (Cohort 1)Single dose of AZD3152 300 mg IM on Visit 2 Day 1 | Biological | Cohort 1 - AZD3152 300 mg IM direct anterolateral thigh injection |
| Placebo (Cohort 1)Single dose of Placebo IM on Visit 2 Day 1 | Biological | Cohort 1 - Placebo IM direct anterolateral thigh injection |
| AZD3152 (Cohort 2)Single dose of AZD3152 600 mg IM on Visit 2 Day 1 | Biological | Cohort 2 - AZD3152 600 mg IM direct anterolateral thigh injection |
| Placebo (Cohort 2)Single dose of Placebo IM on Visit 2 Day 1 | Biological | Cohort 2 - Placebo direct anterolateral thigh injection |
| AZD3152 (Cohort 3)Single dose of AZD3152 1200 mg IV on Visit 2 Day 1 | Biological | Cohort 3 - AZD3152 1200 mg IV administration |
| Placebo (Cohort 3)Single dose of Placebo IM on Visit 2 Day 1 | Biological | Cohort 3 - Placebo IV administration |
Primary outcome
To evaluate the safety and tolerability of AZD3152 - AEs
Time frame: Up to Visit 9 (Day 91)
Occurrence of AEs collected up to Visit 9 (Day 91)
To evaluate the safety and tolerability of AZD3152 - SAEs, MAAEs, and AESIs
Time frame: Up to Visit 12 (Day 361)
Occurrence of SAEs, MAAEs, and AESIs collected up to Visit 12 (Day 361)
To evaluate the safety and tolerability of AZD3152 - Blood pressure
Time frame: Up to Visit 7 (Day 29)
The following variables will be collected: * Systolic Blood pressure * Diastolic Blood pressure
To evaluate the safety and tolerability of AZD3152 - Pulse rate
Time frame: Up to Visit 7 (Day 29)
Pulse rate will be collected
To evaluate the safety and tolerability of AZD3152 - Axillary temperature
Time frame: Up to Visit 7 (Day 29)
Axillary temperature will be collected
To evaluate the safety and tolerability of AZD3152 - Respiratory rate
Time frame: Up to Visit 7 (Day 29)
Respiratory rate will be collected
To evaluate the safety and tolerability of AZD3152 - PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
Time frame: Up to Visit 7 (Day 29)
PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval will be recorded
To evaluate the safety and tolerability of AZD3152 - Heart rate
Time frame: Up to Visit 7 (Day 29)
Heart rate will be recorded
To characterise the Serum Pharmacokinetics of AZD3152 - Concentration at the end of infusion (Ceoi) (after intravenous only)
Time frame: Up to Visit 12 (Day 361)
AZD3152 concentration over time and Pharmacokinetics parameters
To characterise the Serum Pharmacokinetics of AZD3152 - Maximum concentration (Cmax)
Time frame: Up to Visit 12 (Day 361)
AZD3152 concentration over time and Pharmacokinetics parameters
To characterise the Serum Pharmacokinetics of AZD3152 - Time to maximum concentration (tmax)
Time frame: Up to Visit 12 (Day 361)
AZD3152 concentration over time and Pharmacokinetics parameters
To characterise the Serum Pharmacokinetics of AZD3152 - Terminal half-life (t½)
Time frame: Up to Visit 12 (Day 361)
AZD3152 concentration over time and Pharmacokinetics parameters
To characterise the Serum Pharmacokinetics of AZD3152 - Area under the concentration-time curve at the last measured time point (AUClast)
Time frame: Up to Visit 12 (Day 361)
AZD3152 concentration over time and Pharmacokinetics parameters
To characterise the Serum Pharmacokinetics of AZD3152 - Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Time frame: Up to Visit 12 (Day 361)
AZD3152 concentration over time and Pharmacokinetics parameters
To evaluate the safety and tolerability of AZD3152 - Haematology - White blood cell count
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - White blood cell count
To evaluate the safety and tolerability of AZD3152 - Haematology - Red blood cell count
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Red blood cell count
To evaluate the safety and tolerability of AZD3152 - Haematology - Haemoglobin
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Haemoglobin
To evaluate the safety and tolerability of AZD3152 - Haematology - Haematocrit
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Haematocrit
To evaluate the safety and tolerability of AZD3152 - Haematology - Mean corpuscular volume
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Mean corpuscular volume
To evaluate the safety and tolerability of AZD3152 - Haematology - Mean corpuscular haemoglobin
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Mean corpuscular haemoglobin
To evaluate the safety and tolerability of AZD3152 - Haematology - Mean corpuscular haemoglobin concentration
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Mean corpuscular haemoglobin concentration
To evaluate the safety and tolerability of AZD3152 - Haematology - Neutrophils absolute count
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Neutrophils absolute count
To evaluate the safety and tolerability of AZD3152 - Haematology - Lymphocytes absolute count
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Lymphocytes absolute count
To evaluate the safety and tolerability of AZD3152 - Haematology - Monocytes absolute count
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Monocytes absolute count
To evaluate the safety and tolerability of AZD3152 - Haematology - Eosinophils absolute count
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Eosinophils absolute count
To evaluate the safety and tolerability of AZD3152 - Haematology - Basophils absolute count
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Basophils absolute count
To evaluate the safety and tolerability of AZD3152 - Haematology - Platelets
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Platelets
To evaluate the safety and tolerability of AZD3152 - Haematology - Reticulocytes absolute count
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Reticulocytes absolute count
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Sodium
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Sodium
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Potassium
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Potassium
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Blood urea nitrogen
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Blood urea nitrogen
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Creatinine and estimated glomerular filtration rate
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Creatinine and estimated glomerular filtration rate
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Albumin
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Albumin
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Calcium
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Calcium
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Phosphate
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Phosphate
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Glucose
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Glucose
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - C reactive protein
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - C reactive protein
To evaluate the safety and tolerability of AZD3152 - Alkaline phosphatase
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Alkaline phosphatase
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Alanine aminotransferase
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Alanine aminotransferase
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Aspartate aminotransferase
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Aspartate aminotransferase
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Gamma glutamyl transpeptidase
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Gamma glutamyl transpeptidase
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Total bilirubin
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Total bilirubin
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Unconjugated bilirubin
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Unconjugated bilirubin
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Conjugated bilirubin
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Conjugated bilirubin
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Creatine kinase
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Creatine kinase
To evaluate the safety and tolerability of AZD3152 - Serum Clincal Chemistry - Troponin T and I
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Troponin T and I
To evaluate the safety and tolerability of AZD3152 - Urinalysis - Glucose
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Glucose
To evaluate the safety and tolerability of AZD3152 - Urinalysis - Blood
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Blood
To evaluate the safety and tolerability of AZD3152 - Urinalysis - Microscopy
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Microscopy
To evaluate the safety and tolerability of AZD3152 - Urinalysis - Protein
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Protein
To evaluate the safety and tolerability of AZD3152 - Coagulation - International normalised ratio
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - International normalised ratio
To evaluate the safety and tolerability of AZD3152 - Coagulation - Activated partial thrombin time
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Activated partial thrombin time
To evaluate the safety and tolerability of AZD3152 - Coagulation - Prothrombin time
Time frame: Up to Visit 7 (Day 29)
The following will be collected: - Prothrombin time
2 secondary outcomes
To evaluate the Anti-Drug Antibody responses to AZD3152 in serum
Time frame: Up to Visit 12 (Day 361)
The serum neutralising responses against SARS-CoV-2 using geometric mean titer (GMT) and geometric mean fold rise (GMFR) from baseline
Time frame: Up to Visit 12 (Day 361)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD3152 (Cohort 1), AZD3152 (Cohort 2) and AZD3152 (Cohort 3) in people with COVID-19, SARS-CoV-2, run by AstraZeneca at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of AZD3152 - AEs (time frame: Up to Visit 9 (Day 91)). The study lists 53 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.